RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is not yet known whether ketamine hydrochloride given together with the best pain management is more effective than a placebo given together with the best pain management in treating neuropathic pain in patients with cancer.

PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together with the best pain management to see how well it works compared with giving a placebo together with the best pain management in treating cancer patients with neuropathic pain.

Effect of the intervention on quality-of-life scores (based on Euroqol thermometer), anxiety and depression (based on HAD scale), and opioid requirements [ Designated as safety issue: No ]

Estimated Enrollment:

214

Study Start Date:

April 2009

Estimated Primary Completion Date:

October 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine whether ketamine hydrochloride given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone in patients with cancer.

Secondary

To compare initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire.

To compare difference in overall pain between the study arms based on the pain-intensity visual-analogue score (VAS).

To compare difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale.

To assess worst pain score (index neuropathic site) between the two arms.

To compare patient distress between the two arms based on NCCN Distress Thermometer.

To assess the side effects and tolerability of trial drug.

To assess the effect of intervention on quality of life scores (based on Euroqol thermometer), anxiety and depression (based on HADS), and opioid requirements.

OUTLINE: This is a multicenter study.

Stage 1 (Run-in Period): Opioid doses are optimized, under a defined schedule, for up to a maximum of 10 days to ensure that all patients are on an optimized and stable regimen* prior to randomization. Following the run-in-period, patients undergo reassessment. Patients who have improved pain scores (i.e., < 4/10 on the visual-analogue score in the past 24 hours or < 5 McGill Sensory Scale Score) are taken off the study. Patients whose scores have not improved continue on to Stage 2 of the study.

NOTE: *Stable regimen is defined as the same dose of controlled release and no more variation than 2 breakthrough opioid doses over the normal for that patient for a period of 48 hours.

Patients are allowed to receive breakthrough opioids at any time during the study.

Patients complete quality-of-life and pain-assessment questionnaires periodically. Some patients may undergo blood sample collection periodically for pharmacogenomics studies at a later date.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed cancer

Index neuropathic pain ≥ 4 on 0-10 (as defined by Leeds Assessment of Neuropathic Symptoms and Signs) that is related to underlying malignancy or resulting from treatment received for this malignancy

McGill Sensory Scale Score > 5

Received a trial of an adjuvant analgesic (gabapentin or amitriptyline or both)

PATIENT CHARACTERISTICS:

Life expectancy ≥ 2 months

Fertile patients must use effective contraception

Able to comply with study procedures

Diastolic blood pressure ≤ 100 mm Hg at screening

No seizures in past 2 years

Not actively hallucinating

No cerebrovascular disease (strokes)

No psychotic disorders or cognitive impairment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

At least 6 weeks since prior and no concurrent chemotherapy or radiotherapy that is likely to affect neuropathic pain

No change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study

No concurrent class I antiarrhythmic drugs

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316744